Regulatory Affairs Lead: FDA Submissions & Analytics

Regulatory Jobs; Pennsylvania; Hybrid; USD 129,000 - 203,000; Full time

Benefits offered by this job

401(k) retirement benefits

Hybrid work arrangement

Paid holidays

Job summary

Merck is seeking a RegOps Associate Director to oversee the review, approval, and coordination of FDA promotional submissions for U.S. products. You will lead cross-functional teams and manage contractors, ensuring alignment with FDA regulations and company standards.

The role emphasizes analytics development, predictive modeling, and quarterly performance metrics to drive compliant, efficient submissions and rapid decision-making in a digital environment.

Qualifications

• Minimum 5 years’ experience in the pharmaceutical industry supporting the promotional review process or similar experience in Quality Assurance and/or Regulatory Submission Management, Regulatory Publishing, Submission planning and filing of materials with FDA or health authorities.
• Proficiency with Veeva PromoMats software workflows and reports.
• Proficiency with data reporting software and GenAI tools and agents, including PowerBI, Whiteboard, Copilot, GPT, Google Gemini.

Responsibilities

• Reviews and oversees regulatory submissions to FDA promotional review divisions for all U.S. products.
• Coordinates with Regulatory Affairs teams and other functions to ensure compliant submissions.
• Develops analytics, dashboards, and quarterly metrics to track performance.
• Provides direction to a team of contractors supporting promotional material submissions to FDA.

Skills

Regulatory Affairs Management

Project Management

Negotiation

Analytical Thinking

Cross-functional Collaboration

Education

Bachelor's degree

Tools

Veeva PromoMats

PowerBI

GenAI tools

Job description

Merck is seeking a RegOps Associate Director to oversee the review, approval, and coordination of FDA promotional submissions for U.S. products. You will lead cross-functional teams and manage contractors, ensuring alignment with FDA regulations and company standards.

The role emphasizes analytics development, predictive modeling, and quarterly performance metrics to drive compliant, efficient submissions and rapid decision-making in a digital environment.